MAUDE Adverse Event Report: HILL-ROM BATESVILLE VERSACARE FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P3200K000019

Device Problem Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technical support representative performed troubleshooting over the phone with the account to determine the left foot pedal of the bed needed to be replaced.Per the hill-rom service manual, perform annual preventive maintenance procedures to make sure all versacare® bed components are functioning as originally designed.Hilow motor: examine the motor for the presence and tightness of the attachment hardware.Replace as necessary.Fully raise and lower the bed.If the bed does not fully raise and lower, calibrate the bed position sensor.Make sure there is no friction or abnormal noises and no audible overload indication can be heard during the movement.Make sure the bed not down led lights up on the control pendant and goes out when the bed is in low position.Replace the defective motor(s) in the event of a malfunction.Troubleshoot in the event of a doubt.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in december 2016.It is unknown if the facility performed any other preventative maintenance on this bed.The account replaced the left foot pedal of the bed to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom technical support received a report from the account stating the bed was raising on its own.The bed was located in the biomed department at the account.There was no patient/user injury reported.(b)(4).

• Brand Name: VERSACARE FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 8005572
• MDR Text Key: 125149311
• Report Number: 1824206-2018-00410
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P3200K000019
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/05/2018
• Initial Date FDA Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1